Bavarian Nordic Announces Initiation of Phase 2 Combination Trial of PROSTVAC, Ipilimumab and Nivolumab in Patients with Localized Prostate Cancer
(Thomson Reuters ONE) -
* Second trial investigating PROSTVAC in combination with checkpoint
inhibitors from Bristol-Myers Squibb
COPENHAGEN, Denmark, April 19, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today announced the initiation of a Phase 2 clinical trial of its
prostate cancer immunotherapy candidate, PROSTVAC (rilimogene), in combination
treatment with YERVOY(®) (ipilimumab) and/or OPDIVO(®) (nivolumab), both of
which are immune checkpoint inhibitors from Bristol-Myers Squibb, as neoadjuvant
therapy in patients with localized prostate cancer.
A lead-in stage will evaluate the safety of the combination of all three drugs
in 10 patients with castration-resistant prostate cancer, followed by enrollment
of up to 55 patients with localized prostate cancer in three cohorts, who will
receive PROSTVAC in combination with either ipilimumab or nivolumab, or a
combination of all three drugs prior to undergoing radical prostatectomy. The
primary endpoint of the study is to evaluate and compare changes in T cell
infiltration in the tumor after neoadjuvant treatment across the three different
cohorts. The principal investigator of the study is James L. Gulley, MD, Senior
Investigator, Center for Cancer Research, part of the National Cancer Institute
(NCI), and the sponsor of the study. Detailed information on the trial can be
found at http://clinicaltrials.gov/ct2/show/NCT02933255.
"There are now eleven ongoing studies of PROSTVAC across various stages of
prostate cancer. In recent years, there has been a growing interest in the
evaluation of the immunotherapy candidate in earlier disease stages, where the
cancer has not yet spread beyond the prostate. We are excited to learn more
about the potential of PROSTVAC for treating this population, and to evaluate
the potential synergistic effects of combining the vaccine with checkpoint
inhibitors, as we believe PROSTVAC may enhance the clinical activity of these
drugs," said Paul Chaplin, President & Chief Executive Officer of Bavarian
Nordic.
This is the second trial conducted in collaboration with Bristol-Myers Squibb.
The first trial was initiated in October 2016, and is investigating the
combination treatment of PROSTVAC and ipilimumab at the University of
California, San Francisco (UCSF), also in a neoadjuvant setting.
For patients interested in enrolling in this clinical trial, please call NCI's
toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or
see the website: https://trials.cancer.gov/ and search for NCT02933255.
About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec or "rilimogene") is a
prostate specific antigen (PSA)-targeted immunotherapy candidate designed to
enhance or stimulate the body's immune response, specifically T cells that will
target and kill prostate cancer cells, altering the course of the disease and
improving overall survival (OS) of patients with prostate cancer. A robust data
package has been established that includes 19 ongoing or completed clinical
studies, comprising more than 2,000 patients of which more than 1,100 patients
have been actively treated with PROSTVAC, which has been generally well-
tolerated. A pivotal Phase 3 clinical trial in 1,297 patients, designed to
determine if PROSTVAC extends the overall survival for patients with
asymptomatic or minimally symptomatic metastatic castration-resistant prostate
cancer (mCRPC) has completed enrollment and top-line data are anticipated in
2017.
The combination of PROSTVAC and ipilimumab was previously investigated in an
NCI-sponsored Phase 1 trial in mCRPC patients, indicating improved survival for
the treatment regimen when compared to the predicted survival (J Clin Oncol
33, 2015 (suppl 7; abstr 172)). This improved effect is believed to be due to
PROSTVAC's ability to stimulate an anti-prostate cancer immune response combined
with the ability of checkpoint inhibitors to make the anti-cancer immune
response more effective.
PROSTVAC is being developed in collaboration with the Center for Cancer
Research, part of the intramural research program of the National Cancer
Institute under a Cooperative Research and Development Agreement.
More information available at http://www.bavarian-
nordic.com/pipeline/prostvac.aspx.
About ipilimumab and nivolumab
Ipilimumab and nivolumab are immune checkpoint inhibitors developed and marketed
by Bristol-Myers Squibb. Ipilimumab is a CTLA-4 antibody, which is approved by
the FDA for the treatment of melanoma. Nivolumab is a PD-1 antibody, which is
approved for the treatment of patients with NSCLC in the second line setting,
among other indications. These immune checkpoint inhibitors work by targeting
molecules that serve as checks and balances in the regulation of immune
responses. By blocking inhibitory molecules or, alternatively, activating
stimulatory molecules, these treatments are designed to unleash and/or enhance
pre-existing anti-cancer immune responses.
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the
development, manufacturing and commercialization of cancer immunotherapies and
vaccines for infectious diseases, based on the Company's live virus vaccine
platform. Through long-standing collaborations, including a collaboration with
the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for
infectious diseases, including the non-replicating smallpox vaccine,
IMVAMUNE(®), which is stockpiled for emergency use by the United States and
other governments. The vaccine is approved in the European Union (under the
trade name IMVANEX(®)) and in Canada. Bavarian Nordic and its partner Janssen
are developing an Ebola vaccine regimen, which has been fast-tracked, with the
backing of worldwide health authorities, and a vaccine for the prevention and
treatment of HPV. Additionally, in collaboration with the National Cancer
Institute, Bavarian Nordic has developed a portfolio of active cancer
immunotherapies, including PROSTVAC(®), which is currently in Phase 3 clinical
development for the treatment of advanced prostate cancer. The company has
partnered with Bristol-Myers Squibb for the potential commercialization of
PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on
Twitter (at)bavariannordic.
Forward-looking statements
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control, that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. All such forward-looking
statements are expressly qualified by these cautionary statements and any other
cautionary statements which may accompany the forward-looking statements. We
undertake no obligation to publicly update or revise forward-looking statements
to reflect subsequent events or circumstances after the date made, except as
required by law.
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Press Release
2017-04-19-en:
http://hugin.info/100065/R/2096658/793401.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 19.04.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 537062
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